Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39035 

Our estimate of burden we attribute to 

the reporting provisions in part 202 is 

based on our experience with the 

collection and a review of Agency data. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2

21 CFR section; activity Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Burden per 

disclosure Total hours 

202.1; ad prepared in accordance with part 202 .............................................. 670 111.08 74,425 400 29,770,000 

202.1(j)(1); info. included re. fatalities or serious damage ............................... 1 1 1 40 40 

Total ........................................................................................................... ........................ .......................... 74,426 .......................... 29,770,040 

1There are no capital costs or operating and maintenance costs associated with this collection. 

2 Numbers rounded to the nearest one/one-hundredth. 

Under § 202.1, advertisements for 

human and animal prescription drug 

and biological products must comply 

with the standards described in that 

section. Under § 202.1(j)(1), if 

information that the use of a 

prescription drug may cause fatalities or 

serious damage has not been widely 

publicized in the medical literature, a 

sponsor must include such information 

in the advertisements for that drug. 

Based on a review of Agency data we 

estimate an average of 29,770,040 hours 

is incurred annually by respondents in 

complying with third-party disclosure 

requirements for prescription drug 

advertising. We assume a placeholder of 

1 for disclosures under § 202.1(j)(1). 

TABLE 3—ESTIMATED ANNUAL DISCLOSURE BURDEN DISCUSSED IN AGENCY GUIDANCE

Information collection recommendations Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 

(in hours) 

Total hours 

Product name placement, size, and prominence in promotional labeling and 

advertisements’ disclosures .......................................................................... 715 190.3 136,069 3 408,207 

The placement, size, prominence, and 

frequency of the proprietary and 

established names for human 

prescription drugs, including 

prescription biological products, and 

animal prescription drugs are specified 

in labeling and advertising regulations 

(§§ 201.10(g) and (h); 202.1(b)–(d)). 

Based on Agency data, we estimate that, 

for human and animal prescription 

drugs and prescription biological 

products, an average of 715 firms 

disseminate approximately 136,069 

advertisements and promotional pieces 

each year. We assume that the burden 

associated with complying with the 

regulatory requirements discussed in 

the guidance would be approximately 3 

hours per response. 

We have adjusted our estimate 

upward to reflect increases in 

prescription drug advertisements and 

associated disclosures. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15648 Filed 7–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0387] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recommended 

Content of Medical Product 

Communications That Are Consistent 

With the Food and Drug 

Administration-Required Labeling and 

Recommendations for Drug and 

Device Manufacturer Communications 

With Payors, Formulary Committees, 

and Similar Entities 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by August 23, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control numbers for the collections of 

information are 0910–0856 and 0910– 

0857. Also include the FDA docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St. North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

I. Medical Product Communications 

That Are Consistent With the FDARequired Labeling—Questions and 

Answers 

OMB Control Number 0910–0856— 

Extension 

This information collection supports 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) and FDA’s 

implementing regulations that govern 

drug and device labeling and 

prescription drug and restricted device 

advertising. Section 502(a) of the FD&C 

Act (21 U.S.C. 352(a)) specifies that a 

drug or device shall be deemed to be 

misbranded if its labeling is false or 


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39036 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

misleading in any particular, and that 

labeling may be considered misleading 

if it fails to reveal material facts about 

the product being promoted, including 

facts that are material in light of the 

representations made in a promotional 

piece (section 201(n) of the FD&C Act 

(21 U.S.C. 321(n))). Similarly, under 

sections 201(n) and 502(n) of the FD&C 

Act and FDA’s implementing 

regulations (21 CFR 202.1(e)(5)(i) and 

(iii)), an advertisement for a prescription 

drug must not be false or misleading 

with respect to side effects, 

contraindications, or effectiveness, or 

fail to reveal material facts about the 

product being advertised, including 

facts that are material in light of the 

representations made in a promotional 

piece. The FD&C Act also specifies that 

restricted device advertisements must 

not be false or misleading (section 

502(q)(1)) and must reveal facts that are 

material about the product being 

advertised (section 201(n)). 

To assist respondents with drug and 

device labeling requirements and 

prescription drug and restricted device 

advertising, we developed the guidance 

for industry entitled ‘‘Medical Product 

Communications That Are Consistent 

With the FDA-Required Labeling— 

Questions and Answers’’ (June 2018) 

(medical product communications 

guidance), available at https://

www.fda.gov/media/133619/download. 

This medical product communications 

guidance includes recommendations 

that firms consider when developing 

‘‘consistent with the FDA-required 

labeling (CFL)’’ presentations in their 

labeling and advertising materials to 

help ensure the presentations are not 

false or misleading in violation of the 

FD&C Act and FDA’s implementing 

regulations. The guidance also describes 

FDA’s thinking when examining the 

consistency of a firm’s product 

communications with that product’s 

own FDA-required labeling. 

As explained in the guidance, if a firm 

communicates information that is not 

contained in its product’s FDA-required 

labeling but that is determined to be 

consistent with the FDA-required 

labeling, FDA does not intend to rely on 

that communication to establish a new 

intended use that is different from the 

use or uses for which the product is 

legally marketed. Establishing a 

product’s intended uses is an element in 

establishing certain violations under the 

FD&C Act and Public Health Service 

Act. Firms’ communications about their 

products that are consistent with the 

products’ FDA-required labeling but 

that are false or misleading may subject 

a firm to enforcement action under the 

FD&C Act. Thus, the guidance not only 

describes FDA’s thinking on 

communications that are consistent 

with the FDA-required labeling, but also 

provides general recommendations 

intended to help firms comply with 

requirements in the FD&C Act and 

FDA’s implementing regulations for 

conveying information that is consistent 

with the FDA-required labeling in a 

truthful and non-misleading way. The 

medical product communications 

guidance recommends that firms 

accurately represent in the 

communications any study results or 

other data and information that are 

relied upon to support a firm’s CFL 

promotional communication. Other 

recommendations include the clear and 

prominent disclosure of aspects of study 

design and methodology that are 

material for audiences to accurately 

interpret the information being 

presented (e.g., type of study, study 

objectives, product dosage and use 

regimens, control or controls used, 

patient population studied), as well as 

material limitations related to the study 

design, methodology, and results. Also, 

the guidance recommends that firms 

accurately characterize and 

contextualize the relevant information 

about the product, including by 

disclosing unfavorable or inconsistent 

findings. In addition, the guidance 

recommends that firms disclose material 

contextual information from the FDArequired labeling in these 

communications, such as data and 

information from studies in the FDArequired labeling that are relevant to the 

data or information presented in the 

CFL promotional communication. 

The recommendations will help 

ensure that health care professional and 

consumer audiences receive truthful 

information about the benefits and risks 

of drugs and devices in firms’ CFL 

promotional communications and that 

material contextual information is 

included in these communications so 

that audiences are not misled. Accurate 

information helps these audiences know 

whether drugs or devices may be 

appropriate for them or their patients 

and know what they can expect to 

experience when prescribing or using 

these products. 

In the Federal Register of May 10, 

2021 (86 FR 24868), we published a 60- 

day notice requesting public comment 

on the proposed collection of 

information. Two comments were 

received; one appearing to question the 

effectiveness of the information 

collection and the other offering its 

support. Neither comment suggested 

FDA revise its estimate of the attendant 

information collection. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Information collection activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 

Recommended information to be included when firms 

choose to disseminate communications that are consistent with the FDA-required labeling ............................. 324 30 9,720 4 38,880 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Since our last request for OMB 

approval, we have made no adjustments 

to the currently approved burden 

estimate. 

II. Recommendations for Drug and 

Device Manufacturer Communications 

With Payors, Formulary Committees, 

and Similar Entities 

OMB Control Number 0910–0857— 

Extension 

This information collection also 

supports implementation of section 

502(a) of the FD&C Act and applicable 

Agency regulations. Section 502(a)(1) of 

the FD&C Act provides that a drug or 

device is deemed to be misbranded ‘‘[i]f 

its labeling is false or misleading in any 

particular.’’ Under longstanding FDA 

practice and FDA’s statute and 

regulations, and under case law, 


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Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 39037 

labeling encompasses more than merely 

the label of the drug, but extends to 

other written, printed, or graphic matter 

‘‘accompanying such article’’ (section 

201(m) of the FD&C Act; see also 21 CFR 

1.3(a)). Section 502(a) of the FD&C Act 

also includes a provision about 

communication of health care economic 

information (HCEI) to payors through 

labeling or advertising. To assist 

respondents in this regard, we 

developed the guidance for industry and 

review staff entitled ‘‘Drug and Device 

Manufacturer Communications With 

Payors, Formulary Committees, and 

Similar Entities—Questions and 

Answers’’ (June 2018) (drug and device 

communications guidance), available at 

https://www.fda.gov/media/133620/ 

download. 

This drug and device communications 

guidance includes recommendations 

regarding information firms should 

include in HCEI for prescription drugs 

if they choose to disseminate such 

materials (HCEI materials) to payors, in 

accordance with section 502(a) of the 

FD&C Act. Specifically, if a 

manufacturer communicates HCEI for 

approved prescription drugs (including 

biological products that also meet the 

definition of drug under the FD&C Act 

and approved or cleared medical 

devices (collectively referred to as 

medical products)) to payors, FDA 

recommends that firms include in HCEI 

materials disseminated to payors 

information about: (1) Various aspects of 

study design and methodology of an 

economic analysis (i.e., type of analysis, 

modeling technique, patient population, 

perspective or viewpoint, treatment 

comparator, time horizon, outcome 

measures, cost estimates, and 

assumptions); (2) factors that limit 

generalizability of an economic analysis; 

limitations to an economic analysis; and 

(3) sensitivity analyses, if applicable, to 

allow for informed decision making by 

payors. 

Furthermore, FDA recommends that 

firms include other information when 

disseminating HCEI materials, as 

applicable, to provide a balanced and 

complete presentation. Such 

information includes a statement of the 

FDA-approved indication of the drug 

and a copy of the most current FDAapproved labeling. Under section 502(a) 

of the FD&C Act, firms must also 

include a conspicuous and prominent 

statement to describe any material 

differences between the HCEI and the 

FDA-approved labeling. HCEI materials 

should also disclose whether certain 

studies or data sources were omitted 

from an economic analysis and how the 

omission of those studies or data 

sources may alter the conclusions 

presented in the analysis. Moreover, 

FDA recommends that HCEI materials 

disclose important risk information 

associated with the approved use of the 

drug, and pursuant to section 502(a) of 

the FD&C Act, HCEI materials must 

disclose any additional risk information 

related to assumptions that vary from 

the approved labeling. In addition, HCEI 

materials should disclose potential 

financial or affiliation biases to the 

extent reasonably known by firms at the 

time of dissemination. 

The drug and device communications 

guidance provides similar 

recommendations for HCEI materials 

disseminated to payors about approved 

or cleared devices. 

If firms choose to make 

communications to payors about 

unapproved products or unapproved 

uses of approved or cleared products, 

FDA recommends that firms include a 

clear statement with their 

communications that the product or use 

is not approved or cleared and that the 

safety or effectiveness of the product or 

use has not been established. 

In the Federal Register of May 10, 

2021, we published a 60-day notice 

requesting public comment on the 

proposed collection of information. Two 

comments were received; one appearing 

to question the effectiveness of the 

information collection and the other 

offering its support. Neither comment 

suggested FDA revise its estimate of the 

attendant information collection. 

We estimate the burden of this 

collection of information as follows: 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Recommended information to be included when firms 

choose to disseminate HCEI materials to payors 

about approved prescription drugs.

430 10.465 4,500 20 ........................... 90,000 

Recommended information to be included when firms 

choose to disseminate HCEI materials to payors 

about approved or cleared devices.

236 10 2,360 20 ........................... 47,200 

Recommended information to be included when firms 

choose to disseminate information about unapproved products or unapproved uses of approved 

or cleared products.

717 2 1,434 0.5 (30 minutes) ..... 717 

Followup information to payors regarding previously 

communicated information about unapproved products or unapproved uses of approved or cleared 

products.

359 2 718 2 ............................. 1,436 

Total ...................................................................... ........................ ........................ 9,012 ................................ 139,353 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 


khammond on DSKJM1Z7X2PROD with NOTICES
39038 Federal Register / Vol. 86, No. 139 / Friday, July 23, 2021 / Notices 

We have adjusted the estimate of 

burden we associate with the 

information collection 

recommendations in the guidance to 

reflect an increase of 2,000 hours and 

100 responses annually. 

Dated: July 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–15653 Filed 7–22–21; 8:45 am] 

BILLING CODE 4161–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0739] 

International Drug Scheduling; 

Convention on Psychotropic 

Substances; Single Convention on 

Narcotic Drugs; 4F-MDMB-BICA (4FMDMB-BUTICA); Brorphine; 

Metonitazene; Eutylone (bk-EBDB); 

BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom 

(mitragynine, 7-hydroxymitragynine); 

Phenibut; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

inviting interested persons to submit 

comments concerning abuse potential, 

actual abuse, medical usefulness, 

trafficking, and impact of scheduling 

changes on availability for medical use 

of seven drug substances. These 

comments will be considered in 

preparing a response from the United 

States to the World Health Organization 

(WHO) regarding the abuse liability and 

diversion of these drugs. WHO will use 

this information to consider whether to 

recommend that certain international 

restrictions be placed on these drug 

substances. This notice requesting 

comments is required by the Controlled 

Substances Act (CSA). 

DATES: Submit either electronic or 

written comments by August 9, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before August 9, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of August 9, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–N–0739 for ‘‘International Drug 

Scheduling; Convention on 

Psychotropic Substances; Single 

Convention on Narcotic Drugs; 4FMDMB-BICA (4F-MDMB-BUTICA); 

Brorphine; Metonitazene; Eutylone (bkEBDB); BMDP (3,4-Methylenedioxy-Nbenzylcathinone); Kratom (mitragynine, 

7-hydroxymitragynine); Phenibut; 

Request for Comments.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

James R. Hunter, Center for Drug 

Evaluation and Research, Controlled 

Substance Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 5150, Silver Spring, 

MD 20993–0002, 301–796–3156, 

james.hunter@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The United States is a party to the 

1971 Convention on Psychotropic 

Substances (Psychotropic Convention). 

Article 2 of the Psychotropic 

Convention provides that if a party to 

the convention or WHO has information 

about a substance, which in its opinion 


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